D&C Red No. 6

Excipient (pharmacologically inactive substance)

What is it?

FDA has regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. The color additive D&C Red No. 6 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug. The color additive D&C Red No. 6 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.

[1] Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices. Accessed online 8/19/2012. http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm#table1A